With Mandatory Product Listing, FDA Not Looking For Gate To Open Or Close On Supplements
Mandatory product listings would help FDA eliminate gap of missing NDI notifications it expects haven't been filed and other information about ingredients but not establish pre-market approval tool.
You may also be interested in...
With Congress considering mandatory supplement product listing as requested by FDA, trade group asks NIH’s Office of Dietary Supplements to share its experience building and maintaining its label database.
"FDA should consider ways to ensure that prohibited drugs are removed from supplements, perhaps by testing products sold after warning letters and mandating recalls whenever products remain adulterated,” say Pieter Cohen and colleagues in JAMA study.
Senate HELP Committee didn’t add amendments to user fee bill to protect confidential information and prevent FDA over-regulation in an MPL program, trade groups say. MPL proponents join opponents in saying language in S.4348 isn’t the answer.